An Observational Study of RoActemra/Actemra (Tocilizumab)... | NCT01388309

Studies
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

NCT01388309

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

64Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Not provided

Countries

Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jul 4, 2011

First Submission Date that Met QC Criteria

Jul 4, 2011

First Posted Date

Jul 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease activity score (DAS28)		12 months

Secondary Outcomes

Measure	Description	Time Frame
DAS 28 (subgroup on monotherapy)		12 months
DAS 28 (subgroup on 4 mg/kg dose)		12 months
Safety: Incidence of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, >/= 18 years of age
Moderate to severe active rheumatoid arthritis
Inadequate response or intolerance to previous therapy with one or more traditional DMARDs

Exclusion Criteria:

Pregnant or lactating women
Active infection
Positive for hepatitis B, hepatitis C or HIV infection
Concomitant anti-TNF drugs
Contraindications to treatment with RoActemra/Actemra

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Banská Bystrica		975 17	Slovakia

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided